NCT06984224

Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NeuFit - Neurological Fitness and Education · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional clinical trail is to determine the efficacy of the use of the Neubie pulsed direct current electrical stimulation device for the treatment of participants experiencing mechanical low back pain. The main question it aims to answer is: Does treatment with the Neubie improve symptoms and time to resolution of back pain compared to standard of care? Researchers will compare a 12 session treatment physical therapy regimen using the Neubie to standard of care to see if there is a difference in symptom severity and time to resolution. Participants will: * Visit the clinic 2 times a week to undergo active physical therapy treatments with or without electrical stimulation from the Neubie. * Undergo testing and fill out surveys on evaluation and final session on quality of life, disability, pain, and spinal mobility.

Detailed description

To determine the efficacy of direct current (DC) electrical stimulation (the Neubie device) on back pain, patients presenting with mechanical, non-radicular low back pain will enroll in a 4 to 6 week treatment regimen at EA Therapeutic Health. The first session will consist of an intake evaluation session that will include: Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. These tests will serve as baseline (and a within subject control) for the intervention. Participants will then undergo a treatment protocol that incorporates either traditional physical therapy (PT) exercises (standard of care control) or PT exercises with the Neubie utilized concurrently (experimental group). Subjects will undergo an evaluation session prior to starting treatment that includes the Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. The experimental group subjects will undergo 12 sessions of physical therapy over a 4 to 6-week period which include 45 min of various physical therapy exercises concurrently with the Neubie followed by a 15 minute passive Vagus nerve stimulation protocol with the Neubie. Control group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the sacroiliac (SI) joint and exercises for back strengthening and stretching. Experimental group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the SI joint) and exercises for back strengthening and stretching in conjunction with Neubie DC e-stim. Both control and experimental groups will receive a customized Home Exercise Program with exercises to be performed at home 1 time a day.

Conditions

• Back Pain, Low

Interventions

Type	Name	Description
DEVICE	Neubie Direct Current Stimulation Device	Pulsed Direct Current Electrical Stimulation Device

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-05-22
• Last updated: 2025-05-22

Regulatory

• FDA-regulated device study